Role Summary

The Associate QA is part of the Pfizer Global Biotherapeutics Quality Organization and will partner closely with quality, manufacturing and laboratory lines. On-site support is required for this role.

This role is responsible for providing QA support to GMP drug product manufacturing and testing operations to enable the disposition of biologic clinical trial materials. This may include the review of batch records (master and executed), investigations (manufacturing and lab), change controls, CAPAs, SOPs, test methods, laboratory data, and other GMP documentation to ensure compliance with procedures and global board of Health regulations. Candidate will also participate in the QA observation of our drug product medial fill program. Candidate will support and lead the release of raw materials utilized, minimally, in drug product manufacturing.

Role Responsibilities

• Support/lead the release of raw materials utilized in drug product manufacturing as needed.
• Review and approve GMP documents such as executed batch records, investigations (manufacturing and lab), change controls, CAPAs, SOPs, test methods, laboratory data to ensure compliance with global board of Health regulations.
• Participate in the QA observation of our drug product medial fill program.
• Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed.
• Ability to resolve issues within specific role and escalate non-routine issues appropriately.
• Ability to present to peers/management locally and virtually inclusive of communicating with other Pfizer Sites.
• May participate in quality risk management activities.
• May participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.
• Able to seek out and assess internal and external compliance with applicable regulations.
• As a Pfizer colleague, responsible for knowing, understanding and acting in accordance with Pfizer’s values.
• The successful candidate will possess strong interpersonal, teamwork, and collaboration skills.
• Contribute to quality assurance team initiatives and objectives.
• Ability to also take directions from other experienced/senior colleagues within the quality organization.

Qualifications

Must-Have

• Bachelor’s Degree required.
• 2+ years of relevant experience within a GMP environment required.
• Team player with strong interpersonal, organizational, and communications skills are a must.
• Candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.

Nice-to-Have

• Biopharma industry experience, with exposure to FDA and/or international regulatory requirements relative to manufacturing and testing preferred.
• A microbiological background is desirable.
• Science, Engineering, or Technical field of study preferred.

Physical/Mental Requirements

• Mental agility to multi-task a broad scope of different types of quality assurance work.
• Ability to independently problem solve and make recommendations for solutions.
• Role is primarily office setting. Traveling outside between buildings on Andover Pfizer campus is required.
• Role includes leading and/or participating in WebEx meetings and frequent use of Microsoft Applications (e.g. MS Teams).

Non-Standard Work Schedule, Travel, or Environment Requirements

• Role is a standard daytime 40-hour work week.
• Adherence to Pfizer safety practices is a must.
• It is not anticipated that this role will require business travel but it would be minimal if needed.

Other Job Details:

• Last date to apply: 27 SEPTEMBER 2021
• Eligible for Relocation Assistance: NO